Cystocele Clinical Trial
Official title:
Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele
Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis.
Status | Unknown status |
Enrollment | 230 |
Est. completion date | December 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - all patients planned for a cystocele repair Exclusion Criteria: - patients who already have voiding problems before the operation not related to the cystocele - patients that are not capable of understanding our patient information form because of mental status or language |
Country | Name | City | State |
---|---|---|---|
Netherlands | atriumMC | Heerlen | |
Netherlands | Maastricht university medical center | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Atrium Medical Center | Maastricht University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy | 6-8 hours after removal of catheter | ||
Secondary | how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy | 6 weeks after surgery |
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